Device recall
Z-1325-2016: Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and…
FDA device recall · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Recall number (Z-number) | Z-1325-2016 |
|---|---|
| Recall event | 73487 |
| Product | Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and… |
| Product code | KDI |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2017 |
| 510(k) numbers | K080964, K113427, K120017, K120505, K121341 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database